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Label Changes for:

Pradaxa (dabigatran etexilate mesylate) Capsules

October 2015

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

October 2015

WARNINGS AND PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation
  • If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate
Risk of Bleeding

Reversal of Anticoagulant Effect

  • specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding

 

September 2015

ADVERSE REACTIONS

  • *Table 2 and Figure 1 modified (bleeding events)

 

September 2014

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience
  • Table 2 (Bleeding Events) - values are changed in most cells of table. See PI for details

Note: changes also made to 14 CLINICAL STUDIES, 14.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation, see Tables 7 and 8.

 

August 2014

DRUG INTERACTIONS

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation
  • *ticagrelor was added to the list of P-gp inhibitors that do not require a dose adjustment.*

 

December 2013

ADVERSE REACTIONS

Postmarketing Experience
  • Esophageal ulcers

 

April 2013 

BOXED WARNING

WARNING: DISCONTINUATING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE…
 

WARNINGS AND PRECAUTIONS

  • Increased Risk of Stroke with Discontinuation of Pradaxa - Discontinuing Pradaxa in absence of adequate alternative anticoagulation increases the risk of thrombotic events…
 

ADVERSE REACTIONS

Postmarketing Experience
  • Thrombocytopenia
 

MEDICATION GUIDE

What is the most important information I should know about Pradaxa?
  • People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body…

 

November 2012

WARNINGS AND PRECAUTIONS

Risk of Bleeding:
  • Hemodialysis can remove dabigatran; however the clinical experience supporting the use of hemodialysis as a treatment for bleeding is limited.
Patients with Prosthetic Heart Valves
  • The safety and efficacy of PRADAXA has not been studied in patients with prosthetic heart valves. Therefore, use of PRADAXA is not recommended in these patients. 

 

 

January 2012

5 WARNING AND PRECAUTIONS 

5.1 Risk of Bleeding
  • Pradaxa’s anticoagulant activity and half-life are increased in patients with renal impairment.
  • Lack of a specific reversal agent; futility of using vitamin K to affect anticoagulant effect
5.2  Temporary Discontinuation of PRADAXA
  • Discontinuing anticoagulants, including PRADAXA, for active bleeding, elective surgery, or invasive procedures, places patients at an increased risk of stroke. Minimize lapses in therapy.
5.3 Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure
  • Consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA in patients with moderate renal impairment (CrCl 30-50 mL/min). Avoid use of PRADAXA and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) [see Drug Interactions (7) and Use in Specific Populations (8.6)].”

MEDICATION GUIDE

How should I take PRADAXA?
  • Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you 

 

March 2011

DRUG INTERACTIONS

Impact of Other Drugs on Dabigatran/P-gp Inhibitors
  • Dronederone: Exposure to dabigatran is higher when it is administered with dronedarone than when it is administered alone

 

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